My client is an established mid-size global biopharma company with a presence in over 30 countries that has grown their global regulatory team from 7 to 21 people in the past twelve months. They have partnered with us to fill a newly created Global Regulatory Lead position that has been created through innovation and growth. In this highly visible role you will be partnering with Senior Management and global teams to provide strategic vision along with scientific and regulatory leadership in defining the global regulatory strategies for assigned projects. This is a great opportunity for you to jump right into this established collaborative, science driven environment and hit the ground running!
- Lead regulatory strategic decision making that enables projects to meet business and regulatory deliverables
- Ensure regional engagement in global regulatory strategy development and execution
- Lead the development of the global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO). Proactively adapts the strategy to ensure new information is incorporated and includes start-of-the-art regulatory intelligence
- Provide direction to Senior Leadership on emerging trends and strategies
- As the Primary Regulatory Interface on the Core Project Team (CPT) and Clinical Development Team (CDT) for GRA, the GRL advocates and drives the ‘one GRA’ perspective with team stakeholders
Knowledge and Skills:
- Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory
- A bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree (MS/MBA, PhD or MD) is preferred
- Has experience working in matrix teams, and ideally, experience of effectively leading matrix teams.
- Candidates must have awareness and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in at least one key region (ie. EU, US, Japan)
- Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment.
- Demonstrated experience in working with multiple stakeholders, across geographies.